Kornimate/medical-research-clean huggingface dataset:
study of evobrutinib in participants with relapsing multiple sclerosis (rms)

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus interferon-beta-1a (avonex®), once a week intramuscularly in participants with rms.


Eligibility criteria:
inclusion criteria: - participants are diagnosed with rms (relapsing-remitting multiple sclerosis \[rrms\] or secondary progressive multiple sclerosis \[spms\] with relapses) in accordance with 2017 revised mcdonald criteria (thompson 2018) - participants with one or more documented relapses within the 2 years before screening with either: a. one relapse which occurred within the last year prior to randomization, or b. the presence of at least 1 gadolinium-enhancing (gd+) t1 lesion within 6 months prior to randomization - participants have expanded disability status scale (edss) score of 0 to 5.5 at baseline. participants with an edss score \ = 30 days prior to both screening and baseline - female participants must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study - participants have given written informed consent prior to any study-related procedure - other protocol defined inclusion criteria could apply exclusion criteria: - participants diagnosed with progressive ms, in accordance with the 2017 revised mcdonald criteria as follows: a). participants with primary progressive ms. b). participants with secondary progressive ms without evidence of relapse. * disease duration more than (\>) 10 years in participants with an edss =\< 2.0 at screening. * immunologic disorder other than ms, or any other condition requiring oral, intravenous (iv) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled type 2 diabetes mellitus or well controlled thyroid disease. * other protocol defined exclusion criteria could apply.

Keywords: evobrutinib avonex® interferon-beta 1a relapsing multiple sclerosis
community-engaged options to facilitate opioid reduction

Conditions: Chronic Pain

Summary: this study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. due to the covid-19 pandemic, these options will be available via telehealth consultation visits using a computer or smartphone with internet connection. the investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.

participants will be recruited from local primary care practices and asked to complete a baseline survey. they will then meet with a registered nurse via teleconference for a complete pain assessment. at the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.

Eligibility criteria:
inclusion criteria: * enrollment in treatment at the chas perry st or partnering clinic; * age greater than 18 years; * ability to read, speak, and write english; * diagnosed with a chronic, non-cancer-based painful medical condition; * ability to provide informed consent. exclusion criteria: * pregnancy; * diagnosis of a cancer-based painful medical condition; * any other medical or psychiatric condition that the pi or co-pi physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)

Keywords: chronic pain opioid complementary
transcatheter aortic valve implantation with sapien 3 transcatheter heart valve for pure aortic regurgitation

Conditions: Pure Aortic Regurgitation

Summary: the hypothesis is that tavi using a sapien 3 thv is feasible and safe for the treatment of pure ar.

up to now, the balloon-expandable valves have been considered contraindicated for patients with pure ar due to the absence of calcium which is considered necessary for the anchoring of the prosthesis. nonetheless, several cases report have suggested the feasibility of tavi using the sapien xt thv, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses. the new generation balloon-expandable sapien 3 thv has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. these characteristics of the sapien 3 thv might translate into a safer use of this device in patients with pure ar and non-calcified valves. significant ar occurs in 2.0% of individuals of \>75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. as for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. although patients with severe ar have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant ar finally undergo intervention. reasons for no intervention are unknown. even if it has been suggested that ar might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure ar is a small niche of patients for tavi. in terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. however, performing tavi with a device used in the routine practice might be appealing and, importantly, safer. a preliminary case series including 3 patients have suggested the feasibility of tavi with the sapien 3 device for pure ar (urena m, himbert d. jacc, 2016 ). in this study we aim to evaluate the feasibility and long-term safety of the sapien 3 thv in patients with pure ar.

Eligibility criteria:
inclusion criteria: * patients with symptomatic (at least dyspnoea nyha class iii or acute heart failure requiring hospitalisation) and pure ar * contraindication or high risk for surgical aortic valve replacement * echocardiography and computed tomography findings suitable for tavi using a sapien 3 thv exclusion criteria: * contraindication for tavi (active endocarditis, aortic dissection, annuloectasia..) * patients' refusal

Keywords: pure ar tavi sapien 3
effect of epidural analgesia during labor on force of maternal push

Conditions: Labor Pain; Analgesia; Maternal; Procedure

Summary: there are multiple factors that determine progress of normal vaginal delivery. frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions. the purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. we will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. this will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.


Eligibility criteria:
inclusion criteria: * adult (18 years and older) * pregnant women in their third trimester * able to read and speak english * capacity to consent to participate * receiving a labor epidural catheter during their labor and delivery at hfh-main exclusion criteria: * severe cardiac disease * people who are unable/medically recommended not to perform valsalva maneuvers * people who are not undergoing labor epidural analgesia
clavipectoral fascia plane block for clavicle surgery

Conditions: Clavicle Injury; Clavicle Fracture

Summary: the pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (cpb). cpb was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. cpb may be an alternative to interscalene brachial plexus block. the aim of this study is to evaluate the efficacy of the us-guided cpb for postoperative analgesia management compare to no intervention control group after clavicle surgery. the primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (vas), adverse effects related with opioids (allergic reaction, nausea, vomiting).

clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. the pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (cpb). cpb was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. the clavipectoral fascia covers the clavicular site of the pectoralis major muscle. it provides the potential interfascial space between the clavicle and the pectoralis major muscle. cpb provide effective analgesia after clavicle surgery. it is also easy to perform. with this advantage and its analgesic effectiveness for clavicle surgery, cpb may be an alternative to interscalene brachial plexus block. however, randomized clinical efficacy trials are needed to investigate the effectiveness of cpb for clavicle fractures. in the literature, data about cpb is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture the aim of this study is to evaluate the efficacy of the us-guided cpb for postoperative analgesia management compare to no intervention control group after clavicle surgery. the primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (vas), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i-ii * scheduled for clavicle surgery under general anesthesia exclusion criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who do not accept the procedure

Keywords: clavicle fracture clavipectoral fascia plane block postoperative analgesia
a registered cohort study on wilson's disease

Conditions: Wilson's Disease

Summary: the aim of this study is to determine the clinical spectrum and natural progression of wilson's disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with wilson's disease to optimize clinical management.


Eligibility criteria:
inclusion criteria: * patients with the genetic diagnosis of wilson's disease * asymptomatic wilson's disease carriers * relatives of wilson's disease patients or carriers * unrelated healthy controls * participants or parent(s)/legal guardian(s) willing and able to complete the informed consent process exclusion criteria: \* participants are unable to comply with study procedures and visit schedule

Keywords: wilson's disease nature history genetics
personality and eating behaviors in morbidly obese patients

Conditions: Eating Behaviors; Affective Symptoms

Summary: the aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery. hypothesis: as compared with usual care, cognitive behavioral therapy and motivational interviewing-based (cbt/mi) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.

obesity is usually treated as a medical disease, prescribing interventions which adhere to the theoretically sound principles.the prevalence of obesity is increasing, and, accordingly, an increasing number of morbidly obese patients are eligible for bariatric surgery. this surgical procedure is highly effective and is often followed by resolution or remission of obesity related comorbidities (e.g. diabetes and obstructive sleep apnea). however, some individuals may have psychological and motivational problems that reduce these beneficial effects. bariatric surgery represents a substantial part of total health care costs, and such costs may increase in the future. another issue is that it is important to prevent post-surgical relapses. hence, there is every reason to increase the effect and efficacy of both conservative treatments and bariatric surgery. clinically the investigators meet patients who regain their weight post-surgically, and the investigators have some experience that these patients may display more dysfunctional eating than those who are able to maintain a lower target weight. given the expected outcome of the rct, the autonomous motivation for lifestyle changes will be increased. lowering dysfunctional eating, as well as increasing the probability of better success in preoperative weight loss, may help the patient to maintain a healthier weight after the surgical procedure. moreover, developing a more tailored intervention for surgery patients may enable new evidence based treatments to be established for these patients.

Eligibility criteria:
inclusion criteria: * patients who have been accepted for bariatric surgery exclusion criteria: * patients suffering from drug and/or alcohol addiction.
phase ii randomized study of early surgery vs multiple sequential antiepileptic drug therapy for infantile spasms refractory to standard treatment

Conditions: Spasms, Infantile; Epilepsy

Summary: objectives: i. evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. ii. assess how infantile spasms interfere with development and whether this is partially reversible. iii. determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.

protocol outline: this is a randomized study. patients are randomly assigned to 1 of 2 treatment groups. the first group undergoes sequential antiepileptic therapy with pyridoxine, corticotropin, valproic acid, carbamazepine, and nitrazepam. the sequence of administration may be altered based on drugs taken prior to entry. any drug may be omitted due to medical contraindications or prior use at study doses or higher. the second group undergoes surgical resection of the zone of cortical abnormality. a functional hemispherectomy is performed for hemiparesis or diffuse unihemispheric dysfunction. if seizures are controlled in the first group at 3 months, the current medication is maintained; if seizures are not controlled, sequential therapy continues to completion. patients experiencing uncontrolled seizures at 6 months cross to surgery. surgical patients experiencing uncontrolled seizures at 3 months or persistent seizures after taper of pre-study antiepileptics cross to drug therapy. all patients are followed at 6 months and 1, 2, 3, 5, 7, and 10 years.

Eligibility criteria:
protocol entry criteria: disease characteristics * infantile spasms or seizures with diagnosis based on the following: short muscular contractions leading to flexion or extension; single or repetitive electroencephalogram (eeg) consistent with diagnosis, i.e., hypsarrhythmia, modified hypsarrhythmia, multifocal spike and wave abnormalities; developmental quotient less than 70 * zone of cortical abnormality in 1 lobe, contiguous multilobes, or 1 hemisphere; confirmed by historical, neurological, and physical evidence, including eeg, closed circuit televised eeg, computed tomography, magnetic resonance imaging, and/or positron-emission tomography; at least 2 abnormal test/imaging results required * no treatable seizure etiology such as metabolic disease or infection prior/concurrent therapy * failed standard therapy, i.e., refractory to corticotropin (at least 40 iu/day for 14 days) as follows: persistent infantile spasms or recurrent spasms after discontinuation or taper or complications requiring dose modification * at least 1 month of standard antiepileptic drug with documented therapeutic blood levels patient characteristics * no medical contraindication to surgery * english-speaking family

Keywords: infantile spasms epilepsy neurologic and psychiatric disorders rare disease seizures
efficacy of 2-liter mixed preparation with bisacodyl plus polyethylene glycol and 4-liter polyethylene glycol for colon cleansing in patients with prior history of colorectal resection

Conditions: Intestinal Cancer

Summary: studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.therefore, which is the best colon preparation in this subgroup of patients is still unknown. polyethylene glycol (peg)-based solutions are the most popular and safest bowel preparation regimens, however the 4-liter volume is often poorly tolerated. more recently, it has been shown that the use of a low volume preparation (2-liter peg solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-liter peg in general population.the primary aim will be to compare the efficacy of 2-l mixed preparation (bisacodyl plus peg) to 4-l peg preparation.


Eligibility criteria:
inclusion criteria: 1. outpatients 2. ≥18 yrs old, 3. prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy exclusion criteria: 1. inpatients 2. emergency colonoscopy 3. comorbidities: congestive heart failure, history of kidney disease, history of solid organ transplant 4. pregnant and/or lactating women
pet/mri evaluation of cardiac amyloid

Conditions: Cardiac Amyloidosis

Summary: cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. this makes it difficult for the heart to function properly. the investigators wish to evaluate if the radiopharmaceutical 18f-florbetaben (neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.

the use of hybrid positron emission tomography/ magnetic resonance imaging (pet/mri) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. it is hypothesized that an increased pet signal of 18f-florbetaben (neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the mri provides the anatomical information. the ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios: 1. diagnosis of cardiac amyloidosis 2. decreasing unnecessary invasive myocardial procedures. the investigators believe this trial will help expand the use of current pet amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old at the time of the scan * patient with known or suspected cardiac amyloidosis. * patient is capable of complying with study procedures exclusion criteria: * patient is pregnant or nursing * metallic implants (contraindicated for mri) * history of renal insufficiency (only for mri contrast administration)
lymphoproliferative disorders after diagnosis of childhood acute lymphoblastic leukemia/lymphoma

Conditions: Childhood Leukemia and Lymphoma

Summary: lymphoproliferative disorders (lpd) are a major cause of morbidity and mortality in immunodeficient patients. there have been isolated case reports of patients with childhood all who developed lpd after all diagnosis, without undergoing stem cell transplantation, but data regarding such cases are limited. we propose here an international collaboration, to form a comprehensive database of children who developed lpd after diagnosis of acute lymphoblastic leukemia/lymphoma

lymphoproliferative disorders (lpd) are a major cause of morbidity and mortality in immunodeficient patients. these disorders have been extensively described in the post-transplant setting, ie after hematopoietic stem cell (sct) or solid organ (sot) transplant. however, since the 1980's, there have been isolated case reports of patients with childhood all, who developed lpd after diagnosis of all, without undergoing sct. comprehensive information is unavailable regarding the prevalence, clinical manifestations, treatment, outcome and pathogenesis of such disorders in this setting. we propose here an international collaboration, to form a comprehensive database of children who developed lpd during the treatment of acute lymphoblastic leukemia/lymphoma (all/lbl). information will be collected in a de-identified fashion regarding patient characteristics, leukemia and lpd characteristics, treatment and outcome. the aims of this retrospective study are: 1. to build a database of children who developed lpd after diagnosis of all/lbl 2. to investigate the characteristics and outcome of this disorder

Eligibility criteria:
inclusion criteria: * children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed lpd after all/lbl diagnosis exclusion criteria: * age\>30 years

Keywords: childhood leukemia lymphoproliferative disorders ebv